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The European Parliament today backed new rules that will help reduce costs of medicines for people living in the EU and allow EU-based manufacturers to be more competitive globally.

The newly introduced manufacturing and stockpiling waiver will help EU-based producers of generic and biosimilar medicines, copies of brand-name drugs with the identical or almost identical chemical make-up.

The new rules apply to medicinal products protected by a supplementary protection certificate (SPC), an intellectual property right that extends the legal effects of a patent on a medicinal product that has been authorised by national or European regulatory authorities by up to five years.

S&D Group spokesperson for the report, Tiemo Wölken said:

“The new rules will benefit Europeans by making drugs cheaper and help EU based generic medicine manufacturers compete with producers from the rest of the world. Generic and biosimilar drugs have the same high quality as their name brand equivalent, whilst being sold at a fraction of the cost, meaning improved access and lower costs for EU patients. This new waiver will help ensure the sustainability of EU healthcare systems by lowering costs for national healthcare budgets and improving security of supply, reducing counterfeits and uncertainty due to reliance on imports.

“EU based generic and biosimilar companies will be able to manufacture products for the purpose of exporting to third countries where the supplementary protection certificate does not apply. In addition, the S&D has succeeded in introducing a stockpiling waiver. This means that, companies will now also be able to stockpile the drugs during the final six months before the certificate expires in Europe, thereby making it possible to launch the new generic drugs in the EU market directly on day one after the expiration of the certificate.

“I am satisfied that this deal strikes the right balance between safeguarding intellectual property rights and at the same time boosting the competitiveness of the EU based generic and biosimilar producers.”

MEPs involved

WÖLKEN Tiemo

Coordinator
Germany

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